Changing Lifestyle in Children (ALLChange)
January 7, 2016 updated by: University of Dundee
Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?
A lifestyle intervention aimed at improving exercise levels in primary school children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Children 9-11 yrs
Exclusion Criteria:
- Children <9 yrs and >12 yrs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active
|
Programme of change to eating habits, diet and exercise
|
|
Experimental: Active 2
Active
|
Programme of change to eating habits, diet and exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
October 29, 2009
First Submitted That Met QC Criteria
October 29, 2009
First Posted (Estimate)
October 30, 2009
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 7, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2003CV40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.